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ID

32971

Description

Study ID: 101877 Clinical Study ID: SAS101877 Study Title: A randomised, open label, 5-way crossover study to assess the systemic exposure of FP and salmeterol from SERETIDE/ADVAIR 250 without spacer, with Aerochamber -Plus and with -Max spacer, with VOLUMATIC spacer and SERETIDE/ADVAIR 500 DISKUS/ACCUHALER in adult subjects with mild or intermittent asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Advair DISKUS,Seretide Accuhaler; Viani,Seretide Diskus,Seretide Accuhaler,Seretide,Advair DISKUS Study Indication: Asthma The study consists of 5 treatment periods and a follow-up visit. The Screening includes Session 1 Treatment Period 1 includes Session 2 Treatment Period 2 includes Session 3 Treatment Period 3 includes Session 4 Treatment Period 4 includes Session 5 Treatment Period 5 includes Session 6 The Follow-up includes Session 7. This document contains the form for ECG-abnormalities. It has to be filled in if ECG-abnormalities occur during study.

Keywords

Versions (3)
  1. 11/14/18 11/14/18 -
  2. 11/22/18 11/22/18 -
  3. 11/23/18 11/23/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

November 22, 2018

DOI

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License

Creative Commons BY-NC 3.0
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    Systemic exposure of fluticasone propionate (FP) and salmeterol from different inhalation devices in adults with mild or intermittent asthma, (Study-)ID: 101877

    English

    Electrocardiogram Abnormalities Form

    1 forms  
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Description

    Subject number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Session Number
    Description

    Session Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1883017
    UMLS CUI [1,2]
    C0750480
    Electrocardiogram
    Description

    Electrocardiogram

    Alias
    UMLS CUI-1
    C1623258
    Date of ECG
    Description

    Day Month Year

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826640
    Time of ECG
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0013798
    Ventricular rate/heart rate
    Description

    Ventricular rate

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1]
    C2189285
    bpm
    ECG
    Description

    ECG result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C0456984
    Were any of the abnormalities clinically significant?
    Description

    If YES, tick all that apply

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C0456984
    Rhythm
    Description

    Rhythm

    Alias
    UMLS CUI-1
    C0232201
    Sinus bradycardia
    Description

    Sinus bradycardia

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0085610
    Sinus tachycardia
    Description

    Sinus tachycardia

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0039239
    Sinus pause
    Description

    Sinus pause

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1955864
    Ectopic supraventricular beats
    Description

    Ectopic supraventricular beats

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0033036
    Junctional rhythm (<= 100/min)
    Description

    Junctional rhythm

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232208
    Supraventricular tachycardia (>100/min)
    Description

    Supraventricular tachycardia

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0039240
    Atrial flutter
    Description

    Atrial flutter

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0004239
    Atrial Fibrillation
    Description

    Atrial Fibrillation

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0004238
    Ectopic ventricular beats
    Description

    Ectopic ventricular beats

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0151636
    Ventricular rhythm
    Description

    comment below

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232216
    If Ventricular rhythm, Comment
    Description

    Comment Ventricular rhythm

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0522055
    UMLS CUI [1,2]
    C3845569
    Pacemaker
    Description

    Pacemaker

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0030163
    P-Wave Morphology
    Description

    P-Wave Morphology

    Alias
    UMLS CUI-1
    C2216025
    Left atrial abnormality (P mitrale)
    Description

    Left atrial abnormality (P mitrale)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0344711
    UMLS CUI [1,2]
    C0232310
    Right atrial abnormality (P pulmonale)
    Description

    Right atrial abnormality (P pulmonale)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0344696
    UMLS CUI [1,2]
    C0232308
    Conduction
    Description

    Conduction

    Alias
    UMLS CUI-1
    C0232217
    First degree AV block (PR interval> 0.20 sec)
    Description

    First degree AV block

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0085614
    Second degree AV block (Mobitz type 1)
    Description

    Second degree AV block (Mobitz type 1)

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0264907
    Second degree AV block (Mobitz type 2)
    Description

    Second degree AV block (Mobitz type 2)

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0155700
    Third degree AV block
    Description

    Third degree AV block

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0151517
    Left axis deviation
    Description

    definied as: QRS axis more negative than - 30 degrees

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232297
    Right axis deviation
    Description

    defined as: QRS axis more positive than + 110 degrees

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232296
    Incomplete right bundle branch block
    Description

    Incomplete right bundle branch block

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0262525
    Right bundle branch block
    Description

    Right bundle branch block

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0085615
    Left bundle branch block
    Description

    Left bundle branch block

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023211
    Nonspecific intraventricular conduction delay
    Description

    defined as: QRS greater than 0,12sec

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1882112
    Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
    Description

    Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0264897
    UMLS CUI [2]
    C0043202
    UMLS CUI [3]
    C0024054
    QT/QTc prolongation
    Description

    QT/QTc prolongation

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0855333
    Depolarization/Repolarization (QRS-T)
    Description

    Depolarization/Repolarization (QRS-T)

    Alias
    UMLS CUI-1
    C1331539
    UMLS CUI-2
    C3279217
    Myocardial infarction, old
    Description

    Myocardial infarction, old

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0155668
    Myocardial infarction, other
    Description

    comment below

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0027051
    UMLS CUI [1,2]
    C0205394
    If Myocardial infarction, other, Comment
    Description

    Comment Myocardial infarction, other

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0522055
    UMLS CUI [1,2]
    C3845569
    Non-specific ST-T changes
    Description

    Non-specific ST-T changes

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1112720
    Low QRS voltage
    Description

    Low QRS voltage

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2349945
    Other
    Description

    Other

    Alias
    UMLS CUI-1
    C0205394
    Other, specify in comments
    Description

    Other

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0205394
    If other abnormalities, Comment
    Description

    Comment other abnormalities

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0522055
    UMLS CUI [1,2]
    C3845569
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    Similar models

    Electrocardiogram Abnormalities Form

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    text
    C2348585 (UMLS CUI [1])
    Item
    Session Number
    integer
    C1883017 (UMLS CUI [1,1])
    C0750480 (UMLS CUI [1,2])
    Session Number
    Code List
    Session Number
    CL Item
    Session 1 (1)
    CL Item
    Session 2 (2)
    CL Item
    Session 3 (3)
    CL Item
    Session 4 (4)
    CL Item
    Session 5 (5)
    CL Item
    Session 6 (6)
    Item Group
    Electrocardiogram
    C1623258 (UMLS CUI-1)
    Date of ECG
    Item
    Date of ECG
    date
    C2826640 (UMLS CUI [1])
    Time of ECG
    Item
    Time of ECG
    time
    C0040223 (UMLS CUI [1,1])
    C0013798 (UMLS CUI [1,2])
    Ventricular rate
    Item
    Ventricular rate/heart rate
    integer
    C2189285 (UMLS CUI [1])
    Item
    ECG
    text
    C1623258 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    ECG result
    Code List
    ECG
    CL Item
    Normal (N)
    CL Item
    Abnormalities present (A)
    Item
    Were any of the abnormalities clinically significant?
    text
    C1623258 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    ECG Result
    Code List
    Were any of the abnormalities clinically significant?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    Rhythm
    C0232201 (UMLS CUI-1)
    Sinus bradycardia
    Item
    Sinus bradycardia
    boolean
    C0085610 (UMLS CUI [1])
    Sinus tachycardia
    Item
    Sinus tachycardia
    boolean
    C0039239 (UMLS CUI [1])
    Sinus pause
    Item
    Sinus pause
    boolean
    C1955864 (UMLS CUI [1])
    Ectopic supraventricular beats
    Item
    Ectopic supraventricular beats
    boolean
    C0033036 (UMLS CUI [1])
    Junctional rhythm
    Item
    Junctional rhythm (<= 100/min)
    boolean
    C0232208 (UMLS CUI [1])
    Supraventricular tachycardia
    Item
    Supraventricular tachycardia (>100/min)
    boolean
    C0039240 (UMLS CUI [1])
    Atrial flutter
    Item
    Atrial flutter
    boolean
    C0004239 (UMLS CUI [1])
    Atrial Fibrillation
    Item
    Atrial Fibrillation
    boolean
    C0004238 (UMLS CUI [1])
    Ectopic ventricular beats
    Item
    Ectopic ventricular beats
    boolean
    C0151636 (UMLS CUI [1])
    Ventricular rhythm
    Item
    Ventricular rhythm
    boolean
    C0232216 (UMLS CUI [1])
    Comment Ventricular rhythm
    Item
    If Ventricular rhythm, Comment
    text
    C0522055 (UMLS CUI [1,1])
    C3845569 (UMLS CUI [1,2])
    Pacemaker
    Item
    Pacemaker
    boolean
    C0030163 (UMLS CUI [1])
    Item Group
    P-Wave Morphology
    C2216025 (UMLS CUI-1)
    Left atrial abnormality (P mitrale)
    Item
    Left atrial abnormality (P mitrale)
    boolean
    C0344711 (UMLS CUI [1,1])
    C0232310 (UMLS CUI [1,2])
    Right atrial abnormality (P pulmonale)
    Item
    Right atrial abnormality (P pulmonale)
    boolean
    C0344696 (UMLS CUI [1,1])
    C0232308 (UMLS CUI [1,2])
    Item Group
    Conduction
    C0232217 (UMLS CUI-1)
    First degree AV block
    Item
    First degree AV block (PR interval> 0.20 sec)
    boolean
    C0085614 (UMLS CUI [1])
    Second degree AV block (Mobitz type 1)
    Item
    Second degree AV block (Mobitz type 1)
    boolean
    C0264907 (UMLS CUI [1])
    Second degree AV block (Mobitz type 2)
    Item
    Second degree AV block (Mobitz type 2)
    boolean
    C0155700 (UMLS CUI [1])
    Third degree AV block
    Item
    Third degree AV block
    boolean
    C0151517 (UMLS CUI [1])
    Left axis deviation
    Item
    Left axis deviation
    boolean
    C0232297 (UMLS CUI [1])
    Right axis deviation
    Item
    Right axis deviation
    boolean
    C0232296 (UMLS CUI [1])
    Incomplete right bundle branch block
    Item
    Incomplete right bundle branch block
    boolean
    C0262525 (UMLS CUI [1])
    Right bundle branch block
    Item
    Right bundle branch block
    boolean
    C0085615 (UMLS CUI [1])
    Left bundle branch block
    Item
    Left bundle branch block
    boolean
    C0023211 (UMLS CUI [1])
    Nonspecific intraventricular conduction delay
    Item
    Nonspecific intraventricular conduction delay
    boolean
    C1882112 (UMLS CUI [1])
    Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
    Item
    Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
    boolean
    C0264897 (UMLS CUI [1])
    C0043202 (UMLS CUI [2])
    C0024054 (UMLS CUI [3])
    QT/QTc prolongation
    Item
    QT/QTc prolongation
    boolean
    C0855333 (UMLS CUI [1])
    Item Group
    Depolarization/Repolarization (QRS-T)
    C1331539 (UMLS CUI-1)
    C3279217 (UMLS CUI-2)
    Myocardial infarction, old
    Item
    Myocardial infarction, old
    boolean
    C0155668 (UMLS CUI [1])
    Myocardial infarction, other
    Item
    Myocardial infarction, other
    boolean
    C0027051 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Comment Myocardial infarction, other
    Item
    If Myocardial infarction, other, Comment
    text
    C0522055 (UMLS CUI [1,1])
    C3845569 (UMLS CUI [1,2])
    Non-specific ST-T changes
    Item
    Non-specific ST-T changes
    boolean
    C1112720 (UMLS CUI [1])
    Low QRS voltage
    Item
    Low QRS voltage
    boolean
    C2349945 (UMLS CUI [1])
    Item Group
    Other
    C0205394 (UMLS CUI-1)
    Other
    Item
    Other, specify in comments
    boolean
    C0205394 (UMLS CUI [1])
    Comment other abnormalities
    Item
    If other abnormalities, Comment
    text
    C0522055 (UMLS CUI [1,1])
    C3845569 (UMLS CUI [1,2])
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